Travere Therapeutics, Inc. · NASDAQ:TVTX
Travere Therapeutics — Technical Presentation (April 2024)
16 slides from Travere Therapeutics's technical presentation, April 2024
Slide 1: Concomitant Sparsentan and SGLT2 Inhibitors in Patients With IgAN in the PROTECT OLE
Poster WCN24-AB-752 Concomitant Sparsentan and Sodium-Glucose Cotransporter-2 Inhibitors (SGLT2is) in Patients With IgA Nephropathy (IgAN) in the PROTECT Open-Label Extension (OLE) To obtain a PDF of this poster please Priscila Preciado,1 Laura Kooienga,2 Robert Malecki,3 scan the Quick Response (QR
Slide 2: Disclosures
DISCLOSURES • PP and NAMA are employees of Travere Therapeutics, Inc., and may have equity or other financial interests in Travere Therapeutics, Inc. • LK is the PI for sponsor studies from Akebia Therapeutics, AstraZeneca, Boehringer Ingelheim, CARA Therapeutics, Chinook Therapeutics, CSL Behring,
Slide 3: Introduction
INTRODUCTION • Sparsentan is a nonimmunosuppressive, single-molecule, dual endothelin angiotensin receptor antagonist (DEARA)1-3 • In the ongoing PROTECT trial, sparsentan was directly compared with irbesartan in patients with IgAN.4 Based on results from this trial, sparsentan was granted accelerat
Slide 4: Objective
OBJECTIVE • The PROTECT OLE study will investigate the long-term efficacy, safety, and tolerability of sparsentan treatment in adult patients with IgAN ‒ This analysis will assess the safety and efficacy in a subset of patients within the PROTECT OLE period who chose to add SGLT2i treatment to their
Slide 5: Methods: Study Design
METHODS Study Design • Patients who completed the PROTECT double-blind period and met eligibility criteria were enrolled in the PROTECT OLE (NCT03762850) • All patients in the PROTECT OLE will receive sparsentan with a target dose of 400 mg/day for up to 156 weeks • Patients could initiate concomita
Slide 6: Methods: Eligibility Criteria and Statistical Analysis
METHODS Eligibility Criteria • Key inclusion criteria ‒ Enrollment and active participation in the PROTECT OLE period while continuing sparsentan treatment ‒ Initiation of an SGLT2i as concomitant medication during the OLE period • Key exclusion criterion ‒ Enrollment in the randomized PROTECT OLE S
Slide 7: Results: Patient Population
RESULTS Patient Population • At data cutoff, 39 patients had received sparsentan with concomitant SGLT2i treatment in the OLE period ‒ Five patients discontinued the OLE, including 2 who first discontinued SGLT2i treatment and then discontinued the OLE ‒ Discontinuations were due to kidney replaceme
Slide 8: Table 1. Patient Demographics
RESULTS Table 1. Patient Demographics Patients Baseline characteristic* (N=39) Sex, n (%) Male 28 (72) Female 11 (28) Race, n (%) White 25 (64) Asian 11 (28) Black/African American 2 (5) Other 1 (3) Ethnicity, n (%) Not Hispanic/Latino 38 (97) Hispanic/Latino 1 (3) Age at baseline visit, mean (SD),
Slide 9: Table 2. Baseline Clinical Characteristics and Medication Use
RESULTS Table 2. Baseline Clinical Characteristics and Medication Use Patients Baseline characteristic (N=39) Clinical measurements BMI, mean (SD), kg/m2 28.4 (4.59)* Body weight, mean (SD), kg 85.4 (23.13)* Systolic blood pressure, mean (SD), mm Hg 126.2 (12.65)* Diastolic blood pressure, mean (SD)
Slide 10: Results: Safety
RESULTS Safety • Twenty-six patients (67%) had a TEAE (Table 3) • Body weight (Figure 1) and blood pressure (systolic and diastolic; Figure 2) remained relatively stable over time following the addition of an SGLT2i to sparsentan treatment Table 3. Summary of TEAEs Patients TEAEs* (N=39) Patients wi
Slide 11: Figure 1. Body Weight Over Time
RESULTS Figure 1. Body Weight Over Time 120 Body weight, mean (SD), kg 100 80 60 40 20 0 Baseline* Week 12 Week 24 Week 36 Week 48 n 37 28 23 16 14 OLE, open-label extension; SGLT2i, sodium-glucose cotransporter-2 inhibitor. *Baseline was defined as the OLE visit closest to the SGLT2i start (ie, bef
Slide 12: Figure 2. Systolic and Diastolic Blood Pressure Over Time
RESULTS Figure 2. Systolic and Diastolic Blood Pressure Over Time Systolic Diastolic 160 BP, mean (SD), mm Hg 140 120 100 80 60 40 20 0 Baseline* Week 12 Week 24 Week 36 Week 48 n 37 28 23 16 14 BP, blood pressure; OLE, open-label extension; SGLT2i, sodium-glucose cotransporter-2 inhibitor. *Baselin
Slide 13: Results: Efficacy
RESULTS Efficacy • Combination therapy of sparsentan plus an SGLT2i led to a further reduction in proteinuria for up to 48 weeks (Figure 3) Figure 3. UPCR Over Time 4.0 UPCR, median (IQR), g/g 3.5 3.0 2.5 2.0 1.5 1.0 0.5 0.0 Baseline* Week 12 Week 24 Week 36 Week 48 n 39 26 20 15 12 OLE, open-label
Slide 14: Conclusions
CONCLUSIONS Early clinical experience of patients during the PROTECT OLE period shows that an SGLT2i added to stable sparsentan treatment is generally well tolerated Data are consistent with an additive benefit on proteinuria reduction with combination therapy A randomized substudy within the PROTEC
Slide 15: Acknowledgments
ACKNOWLEDGMENTS • This study is funded by Travere Therapeutics, Inc. Medical writing support was provided by Lise Barnard, PhD, Nicole Lopez, PhD, and Chris Edwards, PhD, CMPP, of Nucleus Global, an Inizio Company, and was funded by Travere Therapeutics, Inc. Preciado P, et al. Poster presented at W
Slide 16: References
REFERENCES 1. Trachtman H, et al. Expert Opin Emerg Drugs. 2020;25(3):367-375. 2. Kowala MC, et al. J Pharmacol Exp Ther. 2004;309(1):275-284. 3. Nagasawa H, et al. Nephrol Dial Transplant. 2022;37:183. 4. Heerspink HJL, et al. Lancet. 2023;401(10388):1584-1594. 5. Filspari (sparsentan). Prescribing
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